- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07343414
Effect of Anesthesia Technique on Surgical View in Shoulder Arthroscopy
Impact of Anesthesia Method on Surgical View and Surgeon Satisfaction During Shoulder Arthroscopy: A Prospective Observational Study
Study Overview
Status
Detailed Description
Shoulder arthroscopy is a minimally invasive surgical procedure where the clarity of the surgeon's visual field is critical for technical success and operative efficiency. The quality of the intraoperative view is heavily influenced by perioperative variables, particularly intraoperative bleeding and hemodynamic stability. Consequently, the anesthetic management strategy-whether General Anesthesia (GA) or Regional Anesthesia (RA) [interscalene nerve block/superficial cervical block] combined with sedation-may significantly alter these conditions. This study aims to prospectively evaluate and compare how these two distinct anesthesia methods impact the clarity of the surgical field, and the operating surgeon's satisfaction.
This is a prospective, observational cohort study will conducted at the Sabuncuoğlu Serefeddin Training and Research Hospital. The study utilizes a naturalistic, non-randomized design. There is no interference with the choice of anesthesia; group assignment is determined solely by routine clinical decision-making and patient preference during the preoperative assessment. Patients are recruited and observationally assigned to one of two cohorts based on the technique administered:
- General Anesthesia Group: Patients who elect or are clinically selected to receive general anesthesia.
- Regional Anesthesia Group: Patients who elect or are clinically selected to receive an interscalene nerve block/superficial cervical block combined with sedation.
Intraoperative physiological variables, including heart rate, systolic and diastolic blood pressure, oxygen saturation, and respiratory rate, will be continuously monitored throughout the procedure. The study will also record the feasibility of implementing controlled hypotension and analyze its correlation with intraoperative bleeding amounts. To provide a holistic comparison between anesthesia methods, the study will track postoperative recovery metrics, including the total duration of surgery and anesthesia. Additionally, postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 1, 2, 4, 8, 16, and 24 hours post-procedure. The incidence of opioid-related side effects, such as nausea and vomiting, will be monitored and recorded during the postoperative period .
Primary Assessment:
- Surgical View Evaluation: The clarity of the surgical field and the extent to which bleeding obscures visualization are evaluated using a 5-point Likert scale (1 = Poor/No Visualization: Severe bleeding that completely obscures the field; surgery is extremely difficult or impossible without constant suction/lavage; 2 = Fair Visualization: Significant bleeding obscuring the field; frequent suction/lavage is required to proceed; 3 = Moderate Visualization: Moderate bleeding; the anatomy is visible, but occasional suction/lavage is needed to maintain a clear view; 4 = Good Visualization: Mild bleeding; the surgical field is clear with only rare need for suction/lavage; 5 = Excellent/Crystal Clear Visualization: No significant bleeding; the surgical field is perfectly clear throughout the procedure.)
Sample Size: Based on a preliminary analysis conducted at our center, a distinct difference in the primary outcome (Surgical view evaluation) was observed between the two groups (RA: 3.1 ± 1.2 vs. GA: 4.0 ± 1.5). To detect this difference with a Power (1-beta) of 0.80 and an alpha error of 0.05, a sample size of 37 patients per group is required. Accounting for a 10% dropout rate, the study will enroll a total of 82 patients (41 in the GA group and 41 in the RA group).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Harun Tolga Duran, M.D.
- Phone Number: +90 985 65 99
- Email: htd0561@gmail.com
Study Contact Backup
- Name: Bülent Meriç Çam, M.D.
- Phone Number: +90 534 815 60 11
- Email: bulentmericcam@gmail.com
Study Locations
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Amasya, Turkey (Türkiye)
- Amasya University Sabuncuoglu Serefeddin Educational and Research Hospital
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Contact:
- Harun Tolga Duran, M.D.
- Phone Number: +90 537 985 65 99
- Email: htd0561@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Volunteers aged 18 to 75 years.
- Patients scheduled for elective shoulder arthroscopy.
- Patients with an ASA (American Society of Anesthesiologists) physical status score of I, II, or III.
- Patients capable of providing informed consent.
Exclusion Criteria:
- Previous surgical procedure performed on the same shoulder.
- Presence of medical contraindications that could affect the choice of anesthesia (coagulopathy, active infection, severe pulmonary diseases)
- Known allergy to local anesthetics or general anesthesia agents
- History of opioid dependence or chronic pain syndrome
- Presence of neurological disorders, particularly those involving the brachial plexus
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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General Anesthesia Group
Patients undergoing elective shoulder arthroscopy who receive general anesthesia as determined by routine clinical practice and patient preference.
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Regional Anesthesia Group
Patients undergoing elective shoulder arthroscopy who receive regional anesthesia [interscalene nerve block/superficial cervical block] combined with sedation as determined by routine clinical practice and patient preference.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Surgical View Clarity Score
Time Frame: Intraoperative (assessed immediately upon completion of wound closure)
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The clarity of the surgical field and the extent to which bleeding obscures visualization are evaluated by the surgeon using a 5-point Likert scale.
The scale ranges from 1 (Poor/No Visualization) to 5 (Excellent/Crystal Clear Visualization).
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Intraoperative (assessed immediately upon completion of wound closure)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Surgeon Satisfaction Score
Time Frame: Intraoperative (assessed immediately upon completion of wound closure)
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The operating surgeon's overall satisfaction with the procedure and the conditions provided by the anesthesia is assessed using a 5-point Likert scale.
The scale is defined as: 1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Very Satisfied.
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Intraoperative (assessed immediately upon completion of wound closure)
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Intraarticular Bleeding Severity
Time Frame: Intraoperative
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The operating surgeon's subjective assessment of the amount of bleeding within the joint during the arthroscopy. This is evaluated using a categorical scale:
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Intraoperative
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Feasibility of Controlled Hypotension
Time Frame: Intraoperative
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Binary assessment of whether controlled hypotension (systolic blood pressure reduction to reduce bleeding) was successfully applied and maintained during the surgery (Yes/No).
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Intraoperative
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Duration of Surgery
Time Frame: Intraoperative
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The time in minutes measured from the start of the incision to the completion of wound closure.
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Intraoperative
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Duration of Anesthesia
Time Frame: Intraoperative
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The total time in minutes from the induction of anesthesia to the cessation of anesthetic effects/emergence.
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Intraoperative
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Postoperative Pain Score (NRS)
Time Frame: Postoperative hours 1, 2, 4, 8, 16, and 24
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Assessment of patient pain intensity using the Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst pain imaginable."
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Postoperative hours 1, 2, 4, 8, 16, and 24
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Incidence of Opioid-Related Side Effects
Time Frame: Postoperative 24 hours
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The occurrence of specific side effects associated with opioid use, including nausea, vomiting, and pruritus (itching).
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Postoperative 24 hours
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Patient Satisfaction Score
Time Frame: Postoperative 24 hours
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The patient's self-reported level of satisfaction with the perioperative process and their comfort level.
This is assessed using a 5-point Likert scale (1 = Very Dissatisfied; 2 = Dissatisfied; 3 = Neutral; 4 = Satisfied; 5 = Very Satisfied)
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Postoperative 24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmet Salih Tüzen, M.D., Izmir Katip Celebi University Ataturk Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025000139-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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